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Usually required in tablet and capsule formulations Lubricants are supposed to help in the reduction of friction: - Between particles during compression and - Between the walls of tablet and the walls of the cavity in which tablet was formed
The lubricants are believed to form a coat around each granule and this effect also gets extended to the tablet surface. The lubricants may show some inherent drawbacks: - Lessen tensile strength (may interfere with the particle particle bonding) - Extension of disintegration and dissolution time (waterproofing properties)
Since primarily lubricants are required to act at the tooling or material interface, lubricants should be incorporated in the final mixing step, after granulation is complete. Concentration should not exceed to 1% for producing maximum flow rate.
Stearic acid & its calcium and magnesium salts are very effective lubricant. Magnesium stearate is very popular as a lubricant and is preferred to calcium stearate. Both of these compounds are alkaline in nature and as such should not be used with acidic drug.
To counteract the waterproofing action of magnesium stearate, surfactants, such as sodium lauryl sulfate can be added to the formulations. The other main activities attributed to a lubricant are: (a) Prevention of sticking of granules to the tooling anti-adherent b) Improvement of granule flow properties glidant
A given lubricant may provide one or more actions to varying degrees but no one material is highly efficient in all categories. Accordingly combinations of lubricants are often selected to provide the necessary total lubricant effect. Careful selection is necessary since some lubricants may interact adversely when in combinations; for example, magnesium stearate and talc (!!!contradiction!!!).
T b : List
soluble Lub icants
Range (%w/w) 0.25 Comments u b u 2 0.25 5 5 5 5 D ub bu . . b
Insoluble Lubricants Stearates(Magnesium Stearate, Calcium Stearate, Sodium stearate) Talc Sterotex Waxes Stearowet Glyceryl behapate(Compritol®888) Liquid paraffin
Table: List of Soluble Lubricants
Water Soluble Lubricants Range (%W/W) Boric acid 1 Sodium benzoate 5 Sodium oleate 5 Sodium acetate 5 Sodium Lauryl sulfate (SLS) 1 5 Magnesium lauryl sulfate (MLS) 1-2
Physical mixture of this lubricant i.e. SLS or MLS with stearates can lead to the best compromise in terms of lubricity, tablet strength and disintegration.
Glidants promote flow of the tablet granulation or powder materials by reducing friction between particles. The commonly used glidants are talcum, starch, colloidal silica, silicates, stearates, calcium phosphate etc. The effect of glidants on the flow of the granules depends on the shape and size of the particles of the glidants and the granules.
As a general rule hydrophilic materials act better on hydrophilic granules and lipophilic ones on the lipophilic granules. The glidants in a particular formulation ensure increasing flow of granules up to a certain optimum concentration. If the concentration of the glidant is taken beyond this, a drag action may come into operation bringing down the rate of flow.
Concentration of starch is common up to 10%, but should be limited otherwise it will worsen the flow of material. Talc is a glidant which is superior to starch; its concentration should be limited because it has retardant effect on dissolution-disintegration profile.
The most important and traditional glidant used is talcum (talc). Recently, silica type glidants are becoming popular due to their small particle size. Magnesium oxide and other magnesium salts are generally added as auxiliaries to silica type glidants where granules have hygroscopic inclinations. The magnesium compounds mop up the excess moisture keeping the granules dry and free flowing.
Antiadherents or anti-sticking agents prevent adhesion of the tablet surface to the die walls and the punches and as a consequence counter the picking or sticking of tablet. Water insoluble lubricants such as magnesium stearate can be used as antiadherents, as can talc and starch.
Table: List of antiadherents
Antiadherent Range (%W/W) 1 5 Comment
Talc Cornstarch Colloidal silica DL-Leucine Sodium lauryl sulfate Stearates
3 10 0.1 0.5 3 10 <1 <1
Lubricant with excellent antiadherents properties Lubricant with excellent antiadherents properties Does not give satisfactory results due to small surface area. Cab-O-Sil® and Syloid® Water soluble lubricant; excellent antiadherents properties Antiadherents with water soluble lubricant Antiadherents with water insoluble lubricant
Lubricants are added to reduce the friction during compression. Glidants improve the flow property of material/granules. Antiadherents avoid sticking to die walls and picking by punches.
Generally, the materials under the labels of lubricants, glidants and antiadherents have more than one quality. Talcum serves all the three functions and most manufacturers still use only talcum for glidant, lubricant and antiadherents actions. However, it is more profitable to use a blend of at least two materials for optimum results.
Colloidal Silica (Aerosil)